Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-11 @ 3:20 PM
Study NCT ID:
NCT02839018
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2016-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrient Pattern Analysis in Critically Ill Patients (NAChO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood, Urine, Muscle biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2016-07-19', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in blood nutrient levels over time in patients with/without ICU-AW (i.e. "ICU-AW group" vs. "no-ICU-AW group". Primary comparison of interest is between day 14 vs. day 6.', 'timeFrame': 'days 6 to 14'}, {'measure': 'Differences in blood nutrient levels over time in patients in "sepsis group" vs. "CNS group". Primary comparison of interest is between day 14 vs. day 6.', 'timeFrame': 'days 6 to 14'}], 'secondaryOutcomes': [{'measure': 'Differences in urine nutrient levels over time in patients with/ without ICU-AW (i.e. "ICU-AW group" vs. "no-ICU-AW group". Primary comparison of interest is between day 14 vs. day 6.', 'timeFrame': 'days 6 to 14'}, {'measure': 'Differences in urine nutrient levels over time in patients in "sepsis group" vs. "CNS group". Primary comparison of interest is between day 14 vs. day 6.', 'timeFrame': 'days 6 to 14'}, {'measure': 'Subgroup analysis: differences in nutrient levels at day 14 vs. day 6 in muscle biopsy samples of ICU long stayer patients in study groups (i.e. "ICU-AW" vs. "no-ICU-AW" and "Sepsis" vs. "CNS").', 'timeFrame': 'days 6 to 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)', 'Muscle Weakness']}, 'descriptionModule': {'briefSummary': 'Little is known about nutritional Parameters that potentially influence the course of intensive-care unit acquired weakness (ICU - AW). The investigators aim to elucidate the nutritional profiles in blood, urine and muscle in respective patients at risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'critically ill patients with severe Sepsis/shock ("Sepsis Group") or intracerebral conditions (CNS Group)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Written informed consent obtained from the patient\'s legal representative and later from the patients (as soon as possible)\n* Individuals diagnosed with severe head trauma or intracerebral hemorrhage ("central nervous system group") or with severe sepsis/ septic shock ("Sepsis group") at any time from ICU admission until day 5 (i.e. day of screening)\n* Patient on the ICU for ≥ 5 days ("ICU long stayer")\n\nExclusion Criteria:\n\n* Language other than German or French\n* Institutionalized Individuals (e.g. prisoners, severe pre-existing mental incapacity)\n* Patients with known pre-existing neurological or psychiatric disease that will make informed consent likely impossible\n* Patients with known pregnancy or known to be lactating will not be included to the investigation. Due to the observational/ diagnostical nature of the study, a pregnancy test will not be performed.\n* Patients on extracorporeal membrane oxygenation (ECMO)\n* Clinical signs of pre-existing malnutrition (Body mass index \\<18)\n* Pre-existing evidence for history of anorexia or bulimia\n* Parenteral nutrition received within last 5 days (for more than 12 hours) or evidence for parental nutrition needed within next 7 days\n* Terminal disease (i.e. life expectancy \\<14 days)\n* Patients with active malignancy\n* Patients on biologicals interfering with metabolism (e.g. infliximab)\n* Patients on chronic steroid medication (i.e. prednisone equivalent dose \\>10mg/day)\n* Patients on neuromuscular blocking agents on a regular basis (i.e. on a repetitive basis within last 48 hours or evidence for need within next 7 days)\n* At screening (day 5): prescribed caloric intake substantially higher (i.e. \\> 150% of caloric need of indirect calorimetry) than indirect calorimetric results (in intubated patients) or i.e. standard-of-care (25 Kcal/kg body weight/day)\n* Severe adipositas defined as BMI \\>40\n* Known pre-existing allergy to standard enteral formulae\n* Subject previously enrolled to an interventional trial that is not considered standard-of-care (e.g. investigation of new medication/drug or medical devices)'}, 'identificationModule': {'nctId': 'NCT02839018', 'acronym': 'NAChO', 'briefTitle': 'Nutrient Pattern Analysis in Critically Ill Patients (NAChO)', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Nutrient Pattern Analysis in Critically Ill Patients Using Omics Technology (NAChO): A Prospective Single-center Observational Trial', 'orgStudyIdInfo': {'id': 'NAChO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Central nervous system (CNS) group', 'description': 'n=50 patients with presumed low prevalence of ICU-AW'}, {'label': 'Severe sepsis/shock group', 'description': 'n=50 patients with presumed high prevalence of ICU-AW'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital, Dept of Intensive Care Medicine', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Joerg C Schefold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inselspital, Bern University Hospital'}, {'name': 'Jukka Takala, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Inselspital, Bern University Hospital'}, {'name': 'Stephan M Jakob, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Inselspital, Bern University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nestec Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}